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    More than 7,000 bottles recalled

    Vaseline Posted on

    “Patients should talk to their healthcare providers about concerns and other treatment options,” the FDA website says.

    The Food and Drug Administration has announced a Class II recall for more than 7,000 bottles of antidepressant due to a chemical.

    The recall was initiated earlier this month, on October 10.

    Duloxetine, reportedly known by brands such as Cymbalta, is used to treat mental disorders such as anxiety and depression, according to the Cleveland Clinic. The product was distributed nationwide and manufactured by Towa Pharmaceutical Europe.

    The agency noted that the drug had the “presence” of the nitrosamine drug substance impurity, N-nitroso-duloxetine.

    According to the FDA, nitrosamine impurities “may increase the risk of cancer if people are exposed to them above acceptable levels and for long periods of time.”

    However, it added: “A person who takes a drug containing nitrosamines at or below acceptable daily intake limits every day for 70 years would not be expected to have an increased risk of cancer.”

    Here’s what we know about the recall:

    More recalls: Honda recalls more than 700,000 cars over fuel leak issues: see list of affected vehicles

    How many bottles have been recalled?

    According to the notice, 7,107 bottles were recalled (delayed-release capsules, including 500 bottles).

    It was classified as Class II, meaning exposure could cause “temporary or medically reversible adverse health effects,” the FDA said.

    What portion of the medication is being recalled?

    According to the FDA, the recalled lot was #220128 and expires in December 2024.

    What should you do if your medication is recalled?

    Officials are urging those who may be on medications with possible nitrosamine to stop taking them.

    “Patients should talk to their healthcare providers about concerns and other treatment options,” the FDA website says.

    What are nitrosamines?

    According to the FDA, nitrosamines are found in water, cured and grilled meats, dairy products and vegetables. Although almost everyone is exposed to trace amounts of nitrosamines, studies link the pollutants to an increased risk of cancer when people are exposed to large amounts for extended periods of time.

    Since 2018, more than 12 million bottles of blood pressure lowering medications such as valsartan and losartan have been withdrawn from the market because they contain nitrosamines.

    The same family of contaminants caused previous recalls of the heartburn drug Zantac, the diabetes drug metformin and the smoking cessation drug Chantix.

    The story has been updated to correct a spelling error.

    Contributors: Ken Alltucker

    Taylor Ardrey is a news reporter for USA TODAY. You can reach her at [email protected].

    Vaseline
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